3N Contact Lenses Adjunct Cleaner is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses with only either OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution or Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution.

Device Description

The proposed device, 3N Contact Lenses Adjunct Cleaner, Model TN083 is an electrical cleaner which is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses using approved contact lens solutions.

The 3N Contact Lenses Adjunct Cleaner adopt the principle of protein electrophoresis, take advantage of the characteristics that negatively charged protein in certain environment and swarm towards positive pole in electric field, then the tear protein will be removed from the surface and air holes of contact lens and absorbed by anodic cleaning probe to achieve the goal of cleaning contact lenses.

The cleaning components of the 3N Contact Lenses Adjunct Cleaner (Model: TN083) consist of a cleaning unit (Power Base) and a partitioned fluid reservoir functioning as the cleaning chamber.

The cleaning chamber is detachably connected to the cleaning unit (power base). In the cleaning chamber, there are two independent cleaning tanks; and there is a cleaning probe on each side of the cleaning tank, namely electrode. In the cleaning unit, the circuit board is fixedly provided with electrode connectors electrically connected to the circuit board. The end of the electrode connector can be stretched and elastically connected with the bottom of the electrode.

AI/ML Overview

The document describes the submission of a 510(k) premarket notification for the "3N Contact Lenses Adjunct Cleaner" (K211361). The study provided is a non-clinical performance test (bench test) to demonstrate the device's deproteinization efficiency and physical compatibility.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Stated Goal)	Reported Device Performance
Protein removal effect/Deproteinization efficiency	Protein cleaning rate > 92.5% for Ocufilcon D and Etafilcon A soft contact lenses (after soaking in artificial tears)
Service life of the device	Protein removal rate of Ocufilcon D soft contact lens was 95% after 0-151 cleaning cycles; shelf life stated as 3 months.
Physical compatibility of contact lenses after cleaning	Deviation of parameters of contact lenses after cleaning complies with relevant requirements in ISO 18369-2:2017.
Functionality after maximum number of cleaning cycles	Not explicitly quantified, but it states "Cleaning Validation was performed to demonstrate functionality is not affected after maximum number of cleaning cycles."

2. Sample size used for the test set and the data provenance

Sample size:
- Deproteinization efficiency and Service life testing: Four kinds of contact lens materials (Johnson and Cooper Optics, Ocufilcon D, Etafilcon A, Comfilcon A, and Senofilcon A). The service life test specifically mentions "151 times" for the Ocufilcon D lens.
- Physical compatibility testing: "3 low modulus high water SCLs (>50wt% water, for example 3 commercial lenses from any of these SCL materials, hioxifilcon A, nelfilcon A or nesofilcon A, or other high water materials)".
Data Provenance: The document does not specify the country of origin for the test data directly. It is a submission by "Suzhou 3N Biological Technology Co., Ltd" from China. The tests are described as "Non-Clinical Data" and "Performance Testing - Bench." It is a retrospective analysis of test data conducted on the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This study is a bench test assessing the physical performance and deproteinization efficiency of the device on contact lenses, not a study involving human interpretation or expert ground truth for medical imaging/diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is a physical performance bench test, not a human reader study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. The submission explicitly states: "This submission does not include any clinical performance testing. It was determined that no such testing was required to demonstrate substantial equivalence."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, this was a standalone device performance test. The tests (deproteinization efficiency, service life, physical compatibility) were conducted solely on the device and contact lenses, without human intervention in the performance measurement itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on measurable physical and chemical properties of the contact lenses before and after treatment by the device. Specifically:

Protein removal: Measured by quantifying protein adsorption/removal percentage.
Physical compatibility: Assessed against the requirements of ISO 18369-2:2017, which defines standards for contact lens physical properties.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI or software algorithm that requires a training set. The "Software Verification and Validation" section refers to software contained within medical devices, but there's no indication of an AI/ML component requiring a "training set" in the context of typical AI model development.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML model for this device.

Summary

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January 13, 2022

Suzhou 3N Biological Technology Co., Ltd Wang Xiaofang Quality and Regulatory Division Manager NO.218 Xinghu Street Suzhou, Jiangsu 215000 China

Re: K211361

Trade/Device Name: 3N Contact Lenses Adjunct Cleaner Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LYL Dated: December 10, 2021 Received: December 10, 2021

Dear Wang Xiaofang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211361

Device Name 3N Contact Lenses Adjunct Cleaner

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image contains a logo with the number 3 in a stylized font, followed by the text "3N科技" and "3N TECH". The number 3 is designed with blue geometric shapes, and the text is in a simple, sans-serif font. The logo appears to represent a technology company named 3N Tech.

510(K) Summary

This 510(k) Summary is provided per the requirements of section 21 CFR 807.92.

The assigned 510(k) number is K211361.

Date Summary Prepared: 1/11/2022.

1. Submitter

Submitter's Name:	Suzhou 3N Biological Technology Co., Ltd
Contact person:	Wang XiaofangHead of Quality and Regulatory
Address:	NO.218, Xinghu Street, BioBay, SIP Suzhou, Jiangsu, PRCChina
Telephone:	0512-62757627/+8617317293095
Email:	xiaofang.wang@3nbio.com

2. Device

Trade Name	3N Contact Lenses Adjunct Cleaner
Common Name	Contact Lenses Adjunct Cleaner
Regulation Description	Contact lens care products
Regulation number	21 CFR 886.5928
Device Class	Class II
Product Code	LYL

3. Predicate Device

RIM-WIDE COMPANIES, INC. LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY, K982115 (RIM-WIDE COMPANIES, INC.) FDA cleared on 01/13/1999.

4. Description of Proposed Device:

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Image /page/4/Picture/0 description: The image shows the logo for 3N Tech. The logo consists of a stylized blue number 3 on the left, followed by the text "3N" in a simple sans-serif font. Below "3N" is the text "3N TECH" in a smaller font. The logo is clean and modern, with a focus on the number 3 and the company's name.

The cleaning components of the 3N Contact Lenses Adjunct Cleaner (Model: TN083) consist of a cleaning unit (Power Base) and a partitioned fluid reservoir functioning as the cleaning chamber.

5. Indications for Use

Comparison of Technological Characteristics with the Predicate Devices 6.

The following table compares the device to the predicate device with basic technological characteristics.

Both subject and predicate devices are electrical contact lens cleaning device and used in conjunction with approved contact lens solutions.

3N Contact Lenses Adjunct Cleaner, TN083 has been compared to LENSERVER Automatic Contact Lens Cleaning Accessory as a predicate device for substantial equivalence. A table comparing the two devices is provided as follows:

Features	Proposed Device(K211361)	Predicate Device(K982115)	Comparison
Product code	LYL	LYL	Same
Regulation No.	21 CFR 886.5928	21 CFR 886.5928	Same
Device Class	Class II	Class II	Same
Indications for Use	3N Contact Lenses AdjunctCleaner is intended for use as an	The LENSERVER AutomaticContact Lens Cleaning Accessory	SimilarNote 1
	adjunct in deproteinization andstorage for soft hydrophiliccontact lenses with only eitherOPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution orBausch & Lomb ReNu MultiPlusMulti-Purpose Solution.	is intended for use as an adjunctin cleaning both soft hydrophilicand rigid gas permeable contactlenses using approved contactlens cleaning solutions.Examples of approved cleaningsolutions indicated for use withthe LENSERVER Automatic forsoft hydrophilic lenses are theAllergan Soft Mate Consept-1Cleaning and DisinfectingSolution, Allergan Soft MateCdrisept-2 Neutralizing andRinsing Solution, or Spray. TheLENSERVER Automatic isindicated for cleaning rigid gaspermeable lenses in conjunctionwith approved solutions such asAllergan Gas Permeable DailyCleaner and AllerganComfortCare Gas PermeableWetting and Soaking Solution.
Technical Principle	Protein electrophoresis	Ultrasonic Cleaning	DifferentNote 2
Mechanism ofAction	Electrical	Electro-mechanical	DifferentNote 3
Configuration	Cleaning Unit(Power Base)Cleaning chamber	Motorized cleaning unitCleaning beaker	SimilarNote 4
Shutdown mode	Automatic timing shutdown	Automatic timing shutdown	Same
Power	Built-in lithium battery	Dry Battery	DifferentNote 5
Material	Medical grade ABS	Medical gradepolymethylpentene	SimilarNote 6
Sterile	Non-sterile	Non-sterile	Same
Single use	No	No	Same
Environment ofUse	home	home	Same

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Image /page/5/Picture/1 description: The image contains a logo for 3N Tech. The logo consists of a blue stylized number 3 on the left, followed by the text "3N 科技" in Chinese characters and "3N TECH" in English. The number 3 is made up of three connected lines, with a small square above the top line.

The following technological differences exist between the subject and predicate devices:

Note 1

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Image /page/6/Picture/0 description: The image contains a logo with the number 3 in a stylized font, along with the text "3N科技" and "3N TECH". The number 3 is in blue and is made up of two parts, a darker blue and a lighter blue. The text "3N科技" is in black and is written in a Chinese font. The text "3N TECH" is in black and is written in a sans-serif font.

The intended use of proposed device and predicate device are similar. The proposed device has storage function. It is expected that the proposed device has more storage functions than the predicate device, just like a contact lens case.

It will not affect the main function and intended use of the device, and indications for use of proposed device is clearly indicated in user manual and label. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.

Note 2 and Note 4

The technical principle and configuration of proposed device and predicate device are different, but it will not affect the main function and the intended use of the device. They are both electrical means. And they are both compliance with electrical safety Standard. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.

Note 3

The mechanism of action of proposed device and predicate device are different, but it will not affect the main function and the intended use of the device. They are both meet the related standards and requirements of physical compatibility. Therefore, this difference will not result in any safety and effectiveness issue of the proposed device.

Note 5

The battery type of proposed device and predicate device are different. They are both compliance with electrical safety standard, it will not raise any safety or effectiveness issue.

Note 6

The main materials of the proposed device and predicate device are different. They are both compliance with medical requirements and standard ISO 10993-1, 10993-11. It will not raise any safety or effectiveness issue.

7. Non-Clinical Data

The following performance data were provided in support of the substantial equivalence determination.

7.1 Biocompatibility testing

The biocompatibility evaluation for the 3N Contact Lenses Adjunct Cleaner is conducted in accordance with the International Standard ISO10993-1 " Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The worst case of the device is considered mucosal membranes contacting for duration of less than 24 hours. And the testing included the following tests:

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Image /page/7/Picture/0 description: The image contains the logo for 3N Tech. The logo consists of a stylized number 3 in blue, with a small square in the upper right corner. To the right of the number 3 is the text "3N科技" in Chinese characters, followed by the text "3N TECH" in English.

Cytotoxicity Study using MTT Method
Guinea Pig Maximization Test
Ocular Irritation test

7.2 Software Verification and Validation

Software documentation, including verification, was provided following FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a minor level of concern.

7.3 Safety and EMC

Testing was performed to verify the basic safety and essential performance of the 3N Contact Lenses Adjunct Cleaner, TN 083. The following tests were performed: IEC 61010-1:2010+A1:2016 Safety requirements for electrical equipment for measurement, control, and laboratory use-Part1: General requirements IEC 61326-1:2013 Electrical equipment for measurement, control and laboratory use-EMC

requirements- Part 1: General requirements

7.4 Performance Testing- Bench

The following tests were performed to demonstrate that the proposed 3N contact lenses adjunct cleaner met the applicable design and performance requirements and support a determination of substantial equivalence. Where applicable, testing was done per applicable ISO and other international standards.

● Deproteinization efficiency testing and Service life testing

Testing was performed to verify the Protein removal effect of the 3N contact lenses adjunct cleaner. This verification test selected lenses of four kinds of materials from Johnson and Cooper Optics. After soaking in artificial tears, Ocufilcon D and Etafilcon A soft contact lenses had a large amount of protein adsorption. The protein cleaning rate was more than 92.5% with 3N contact lenses adjunct cleaner combined with care solution. However, Comfilcon A and Senofilcon A soft contact lenses have very little protein adsorption, so it is impossible to calculate the clearance effect. The protein removal rate of Ocufilcon D soft contact lens was 95% after 3N contact lenses adjunct cleaner was recycled for 0, 151 times. So the shelf life of the 3N contact lenses adjunct cleaner is 3 months.

● Physical compatibility testing

The testing was considerably streamlined just assessing 3 low modulus high water SCLs (>50wt% water, for example 3 commercial lenses from any of these SCL materials, hioxifilcon A, nelfilcon A or nesofilcon A, or other high water materials) with the 3N device.

Deviation of the parameters of contact lenses before and requirements after cleaned by 3N Contact

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Image /page/8/Picture/0 description: The image contains a logo with the number 3 on the left side, and the text "3N科技" and "3N TECH" on the right side. The number 3 is stylized with a blue color scheme. The text "3N科技" is in Chinese characters, and the text "3N TECH" is in English. The logo is likely for a technology company.

Lenses Adjunct Cleaner complies with the relevant requirements in ISO 18369-2:2017.

Cleaning Validation was performed to demonstrate functionality is not affected after maximum number of cleaning cycles. The device was cleaned following the procedure defined in the User's Manual.

7.5 Performance Testing - Animal

This submission does not include any animal performance testing. It was determined that no such testing was required to demonstrate substantial equivalence.

7.6 Performance Testing - Clinical

This submission does not include any clinical performance testing. It was determined that no such testing was required to demonstrate substantial equivalence.

8. Conclusion

From the bench test conducted on the proposed device provided in above, the test result showed that the proposed device can meet the requirements of related standards. Therefore, it can be determined that the proposed devices are Substantially Equivalent (SE) to the predicate device, K982115.

Regulation Number and Section

§ 886.5928 Soft (hydrophilic) contact lens care products.

(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”